Actively Recruiting
A Phase III Randomized Trial Comparing Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance for Frail or Intermediate-Fit Newly Diagnosed Multiple Myeloma Patients Not Suitable for Stem Cell Transplant
Led by SWOG Cancer Research Network · Updated on 2025-06-04
510
Participants Needed
397
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are not eligible for stem cell transplant and are considered frail or intermediate-fit based on age, other health conditions, and functional status. This phase III trial compares three induction regimens followed by either single or double maintenance therapy to see which combination works best to control the cancer and improve survival. The study also examines patient quality of life, safety, and other treatment effects over time. Patients are randomly assigned to one of three treatment groups. The first group receives bortezomib, lenalidomide, and dexamethasone for up to nine 28-day cycles, followed by lenalidomide maintenance. The second group receives daratumumab and hyaluronidase-fihj, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. The third group has the same induction as the second group but receives both daratumumab and lenalidomide during maintenance. Treatments are given by injection or orally on specific days within each cycle, and continue as long as the disease does not progress or side effects are unacceptable. Participants undergo assessments including tumor measurements, blood tests, patient-reported questionnaires, and blood sample banking for future research. After completing treatment, patients are followed up every three months for one year, then every six months for two years, and annually for up to ten years to monitor progression, survival, and quality of life. The main outcomes measured are progression-free survival and overall survival, with additional evaluations of response rates, safety, and symptom reports up to ten years after starting the study.
CONDITIONS
Brief Title
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have documented multiple myeloma meeting standard IMWG diagnostic criteria within 28 days before registration
- Participants must have measurable disease within 28 days before registration defined by specific protein levels in blood or urine
- Participants must be categorized as frail or intermediate fit by the Myeloma Frailty Score Calculator within 28 days before registration
- Frail participants with any kidney dysfunction except dialysis are allowed
- Frail participants must have hemoglobin \u2265 7 g/dL, platelets \u2265 50 x 10^9/L, and absolute neutrophil count \u2265 0.75 x 10^9/L within 28 days before registration
- Intermediate fit participants must have one or more of the following: creatinine clearance <30 ml/min, hemoglobin 7-8 g/dL, platelets 50-75 x 10^9/L, or ANC 0.75-1 x 10^9/L
- Participants must have Revised International Staging System stage III disease if intermediate fit
- Complete medical history and physical exam within 28 days before registration
- Whole body imaging within 60 days before registration (preferably PET/CT)
- Total bilirubin \u2264 2 times institutional upper limit of normal unless Gilbert's disease (\u2264 5 times for Gilbert's)
- AST/ALT \u2264 3 times institutional upper limit of normal within 28 days before registration
- Adequate cardiac function assessed within 14 days before registration; no NYHA class 3 or 4 heart failure
- Controlled diabetes with HbA1C \u2264 7 within 14 days before registration
- HIV-positive participants must be on anti-retroviral therapy with undetectable viral load within 6 months
- Chronic hepatitis B participants must have undetectable viral load on therapy within 28 days
- Hepatitis C participants must be treated and cured or have undetectable viral load within 28 days
- ECOG/Zubrod performance status score 0-2 (score 3 allowed if due to myeloma)
- Consent to specimen banking and patient-reported outcomes in English or Spanish
- Informed consent signed by participant or legally authorized representative
You will not qualify if you...
- Prior systemic therapy for multiple myeloma except emergency corticosteroids, one cycle of non-daratumumab regimen, or palliative radiation completed at least 3 days before study treatment
- Grade 4 peripheral neuropathy
- Uncontrolled blood pressure (SBP >140 mmHg or DBP >90 mmHg) within 14 days before registration
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Pregnant or nursing individuals; effective contraception required for those of reproductive potential
Research Team
S
Sharon Palmer
D
Dana Sparks
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